Air Conduction Assistive Listening Device.Personal Amplifier
FDA 510(k) K970340 · Bellab
510(k) numberK970340
Submission
- Device name
- Air Conduction Assistive Listening Device.Personal Amplifier
- Applicant
- Bellab
Gothenburg, SE - Received
- January 29, 1997
- Decision date
- March 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZI – Device, Assistive Listening
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3320
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043090 | Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional | Phonic Ear, Inc. | 12/23/2004SE |
| K970974 | Williams Sound, Personal FM System, Hearing HelperLZI · Traditional | Williams Sound, LLC | 05/02/1997SE |
| K954748 | Pocketalker ProLZI · Traditional | Williams Sound, LLC | 11/22/1995SE |
| K952057 | Listenaider IILZI · Traditional | National Hearing Aid Dist., Inc. | 06/21/1995SE |
| K934805 | HearitLZI · Traditional | Je Liss & Co., Inc. | 02/07/1994SE |
| K904755 | Acoustiq Listening DeviceLZI · Traditional | Krueger Laboratories | 01/29/1991SE |
Questions and answers
When was Air Conduction Assistive Listening Device.Personal Amplifier cleared by the FDA?
Air Conduction Assistive Listening Device.Personal Amplifier (K970340) received a 510(k) decision of Substantially Equivalent on March 26, 1997, 56 days after the submission was received.
What is the product code of K970340?
The FDA product code is LZI – Device, Assistive Listening, a Class II (moderate risk) device regulated under 21 CFR 874.3320.